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SFDA issues Technical Guidelines for Post-approval Changes of Pharmaceuticals
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To offer scientific guidance to drug manufacturing enterprises in conducting research on post-approval changes of pharmaceuticals, the State Food and Drug Administration (SFDA) recently issued Technical Guidelines for Post-approval Changes of Pharmaceuticals (I) in accordance with Provisions for Drug Registration. For the post-approval changes mentioned in the Technical Guidelines, when the research finds in vivo bioequivalence studies or clinical trials are necessary, supplementary application shall be submitted to the SFDA.
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